The
General Safety Test is an animal test for
the detection of extraneous toxic contaminants and one which is sometimes
undertaken for biological products intended for administration to humans. In
the European Pharmacopoeia, the test is referred to as the ‘Abnormal Toxicity
Test’; whereas in the United States Pharmacopeia, the test is the ‘General
Safety Test’. Aside from some relatively minor differences relating to the size
of the animals used, the numbers required, and with the interpretation of animals
that appear ‘distressed’, the two compendial tests are essentially the same.
In
relation to this test – long past its usefulness – Tim Sandle has written a
review article for GMP Review. The reference is:
For a copy, please contact Tim Sandle
Posted by Dr. Tim Sandle
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